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510(k) Data Aggregation

K Number

Device Name

URESIL DILATOR WITH RADIOPAQUE MARKER

Manufacturer

Date Cleared

1998-04-24

(88 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

URESIL DILATOR WITH RADIOPAQUE MARKER

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

This device is intended to help create a tract for catheter insertion.

Device Description

Not Found

AI/ML Overview

This is a 510(k) summary and not a study. It does not provide the information requested to describe acceptance criteria and study proving device meets the criteria.

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